Osteoarthritis Of Knee Clinical Trial
Official title:
Geniculate Artery Embolization for the Treatment of Knee Pain Secondary to Osteoarthritis
This study is to test a new treatment method, geniculate artery embolization (GAE), to reduce the severity of pain and disability caused by knee osteoarthritis.
Purpose: The primary aims of this study are to determine if geniculate artery embolization
(GAE) will reduce the severity of pain as well as global disability (resulting from the
combination of pain, stiffness and difficulty performing daily activities) caused by knee OA
and if it can be performed safely. The secondary aim is to determine if GAE can result in the
decreased necessity for ongoing conservative OA therapies such as medication therapy and
joint injections.
Participants: Twenty patients with knee osteoarthritis resulting in knee pain that is
refractory to conservative therapies, who are not planning to undergo surgery within 6
months.
Procedures (methods): This will be an open label 24-month pilot study with a small population
undergoing GAE to determine safety and efficacy. Clinical procedures and evaluations will
consist of a preoperative screening assessment to determine if the potential study subject
meets the inclusion and exclusion criteria, enrollment, surgical procedure for geniculate
artery embolization, and follow-up visits at 24 hours, 1, 3 & 6 months. An MRI will be
performed at the 1-month visit to detect a change in synovial vascularity and to exclude
complication.
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